Faset
by Dio Medical Co., Ltd. 227 variants
Faset (FA.IN.0001) is a device classified as Unclassified made by Dio Medical Co., Ltd., cleared under FDA 510(k) K180729 on 28 Jun 2018 and listed in FDA GUDID since 8 Feb 2019 (UDI-DI 08800039825276), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08800039825276 | Date8 Feb 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180729 | Date28 Jun 2018 | StatusActive |
Official records
- AccessGUDID record 08800039825276
- FDA 510(k) database K180729
Across registries
- FDA 510(k) K180729 decided 28 Jun 2018 Active
- FDA GUDID UDI-DI 08800039825276 listed 8 Feb 2019 Listed
Timeline
- Cleared FDA 510(k) K180729
- Listed FDA GUDID 08800039825276
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Bone marrow biopsy needle, single-use
- Model / Ref / Catalog
- A, FA.IN.0001
- Primary DI / UDI-DI
- 08800039825276
- 510(k) Number
- FDA product code
- MRW
- GMDN term
- Bone marrow biopsy needle, single-use
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Unsafe
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